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Nucleoside Metabolic Inhibitor

Venetoclax + Azacitidine for Myelodysplastic Syndrome (Verona Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.
Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Verona Trial Summary

This trial will help researchers learn if venetoclax and AZA combination are safe and effective when compared to AZA and placebo, in participants with newly diagnosed higher-risk MDS.

Who is the study for?
Adults newly diagnosed with higher-risk Myelodysplastic Syndrome (MDS) as per WHO criteria, with less than 20% bone marrow blasts and an ECOG status of <=2. They should not have had previous treatments for MDS or a planned stem cell transplant at the start of the study.Check my eligibility
What is being tested?
The trial is testing Venetoclax tablets combined with Azacitidine (AZA), against AZA with a placebo. Participants will either take Venetoclax orally and receive AZA through injection or infusion, or they'll take a placebo tablet and get AZA similarly.See study design
What are the potential side effects?
Potential side effects may include fatigue, shortness of breath, easy bruising, bleeding under the skin, gastrointestinal symptoms, blood count abnormalities and possible increased risk of infection due to bone marrow suppression.

Verona Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with MDS with less than 20% bone marrow blasts.
Select...
I am eligible for a stem cell transplant but do not have one scheduled.
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I am able to care for myself and perform daily activities.

Verona Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
Complete Remission (CR)
Modified Overall Response (mOR)
+4 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Rhinovirus infection
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Verona Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Venetoclax + Azacitidine (AZA)Experimental Treatment2 Interventions
Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Group II: Arm 2: Placebo + AzacitidineActive Control2 Interventions
Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,574 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,158 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,408 Total Patients Enrolled

Media Library

Azacitidine (Nucleoside Metabolic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04401748 — Phase 3
Myelodysplastic Syndrome Research Study Groups: Arm 2: Placebo + Azacitidine, Arm 1: Venetoclax + Azacitidine (AZA)
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04401748 — Phase 3
Azacitidine (Nucleoside Metabolic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401748 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being enrolled in this trial at present?

"The study in question is not, at present, looking for trial participants. According to the information found on clinicaltrials.gov, this trial was first posted on September 10th 2020 and was last updated November 2nd 2022. Although this particular study isn't recruiting right now, there are two thousand and twenty-one other studies that are actively searching for candidates."

Answered by AI

What are the main illnesses that Venetoclax has been shown to be effective against?

"Not only is induction chemotherapy commonly treated with Venetoclax, but this medication can also be used to help patients suffering from refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI

In how many different medical clinics is this medical study being run today?

"Patients can receive this treatment at Hopital du Sacre Coeur Montreal /ID# 218973 in Montreal, Quebec, Willamette Valley Cancer Institute /ID# 223733 in Eugene, Oregon, Consultants in Medical Oncology and Hematology - Broomall /ID# 233818 in Broomall, Pennsylvania as well as 29 other locations."

Answered by AI

What benefits does this experiment hope to bring about?

"The primary outcome of this study, which will be monitored over the course of Up To 5 Years, is Complete Remission (CR) according to Genentech, Inc., the sponsor of this trial. Additionally, secondary outcomes such as Overall Response (OR)–which is defined OR [complete remission (CR) + partial response (PR)] as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.– , Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline–defined as TI is when the participants who were"

Answered by AI

What other Venetoclax research is out there?

"350 different clinical studies are being conducted on Venetoclax. Of these, 55 are in Phase 3. 11282 research sites are running Venetoclax trials globally, with the majority based in Edmonton, Alberta."

Answered by AI

When did the FDA give their green light to Venetoclax?

"Venetoclax receives a safety score of 3 because there is available evidence from past clinical trials supporting both its efficacy and safety."

Answered by AI

How many guinea pigs are receiving the treatment in this experiment?

"This particular study is not currently looking for patients, as the last update was on November 2nd, 2020. However, there are 1671 other trials for myelodysplastic syndromes and 350 additional trials testing Venetoclax that are presently enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Virginia Cancer Specialists - Gainesville /ID# 223726
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
2020. "Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04401748.
~90 spots leftby Feb 2025
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